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Wax-matrix extended-release niacin vs inositol hexanicotinate: a comparison of wax-matrix, extended-release niacin to inositol hexanicotinate "no-flush" niacin in persons with mild to moderate dyslipidemia.
- Source :
-
Journal of clinical lipidology [J Clin Lipidol] 2013 Jan-Feb; Vol. 7 (1), pp. 14-23. Date of Electronic Publication: 2012 Oct 30. - Publication Year :
- 2013
-
Abstract
- Background: Nicotinic acid (NA), long used for the treatment of dyslipidemia, has shown problems with undesirable side effects and safety issues. Wax-matrix, extended-release niacin (WMER) and inositol hexanicotinate (IHN) have both been formulated to increase patient tolerability. Several trials of WMER demonstrated good efficacy in improving dyslipidemia; however, there are few scientific data on the use of IHN.<br />Objective: This study was designed to compare the efficacy and tolerability of WMER and IHN to each other and placebo to help clinicians make an informed choice of NA agents.<br />Methods: This was a 6-week blinded, placebo-controlled trial comparing 1500 mg/d of WMER with 1500 mg/d IHN. Subjects with mild-to-moderate dyslipidemia (low-density lipoprotein = 130-190/dL) were randomized, after a 4-week diet lead-in period, to three parallel study arms (40 subjects/arm). Diet, pill compliance, and side effects were monitored as well as lipid and blood chemistry profiles (baseline, 6 weeks). A dose-reduction protocol was included for subjects who did not tolerate the 1500-mg dose of NA. A pharmacokinetic substudy was conducted on subjects from the WMER (n = 5) and IHN (n = 5) groups.<br />Results: WMER demonstrated significant improvements in total cholesterol = -11%, low-density lipoprotein = -18%, high-density lipoprotein = +12%, and non-high-density lipoprotein = -15% (P < .001), whereas IHN and placebo showed no significant improvement in lipids. All groups had good medication compliance and treatment tolerance with only one dropout in the WMER group as the result of flushing. Blood chemistries showed small (24%-27%) mean increases in hepatic transaminases; six subjects completed the study at reduced dosage protocol with good lipid results. Pharmacokinetics demonstrated an intermediate release and absorption rate for WMER over 6 hours and IHN showed no evidence of bioavailability.<br />Conclusion: WMER demonstrated good tolerance and efficacy and extended-release kinetics. IHN was well tolerated but was no better than placebo in lipid improvement and showed no evidence of bioavailability.<br /> (Copyright © 2013 National Lipid Association. Published by Elsevier Inc. All rights reserved.)
- Subjects :
- Adult
Blood Chemical Analysis
Cholesterol blood
Delayed-Action Preparations adverse effects
Diet
Double-Blind Method
Dyslipidemias metabolism
Dyslipidemias pathology
Female
Flushing etiology
Half-Life
Humans
Hypolipidemic Agents pharmacokinetics
Lipoproteins, HDL blood
Lipoproteins, LDL blood
Male
Middle Aged
Niacin pharmacokinetics
Nicotinic Acids chemistry
Nicotinic Acids pharmacokinetics
Placebo Effect
Transaminases metabolism
Dyslipidemias drug therapy
Hypolipidemic Agents therapeutic use
Niacin therapeutic use
Nicotinic Acids therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1933-2874
- Volume :
- 7
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Journal of clinical lipidology
- Publication Type :
- Academic Journal
- Accession number :
- 23351578
- Full Text :
- https://doi.org/10.1016/j.jacl.2012.10.004